Quality Assurance Specialist (Senior) Required-Pharmaceutical MNC -Dublin
Quality Assurance Specialist (Senior)
This position sits within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.
Quality review and approval of Validation documentation and SOPs to support site validation activities:
o Review of DS & QRAES documents
o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
o Review of executed validation documents and reports
Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.